Medical Device Manufacturer · US , Richland , MI

Imagyn Surgical - FDA 510(k) Cleared Devices

3 submissions · 2 cleared · Since 1999

Recent clearances: 15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE

3

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Imagyn Surgical Gastroenterology & Urology ✕

2 devices

1-2 of 2

Cleared Aug 17, 2001

22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022

Gastroenterology & Urology · 87d

Cleared Dec 27, 1999

15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE,...

Gastroenterology & Urology · 38d